Associate, ESOQ Regulatory Operations

Job description

Use Your Power for Purpose Every day, everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, grounded in science and risk-based compliance, is both flexible and innovative, always putting the customer first. Whether your role involves development, maintenance, compliance, or analysis through research programs, your contributions are vital and will have a direct impact on patients. Your efforts will ensure that our products meet the highest standards of quality and safety, directly impacting the well-being of patients worldwide. What You Will Achieve In this role, you will: Support Post Approval Changes, initial registrations and/or renewals. Perform preliminary regulatory impact assessment, facilitate discussions and raise the change management records in the relevant GMP system/s. Coordinate the collection of supporting documents for Post Approval Changes, initial registration, renewals, Board of Health (BOH) queries, and regulatory commitments. Act as a liaison between CMOs and internal Pfizer functions to ensure timely progression of change activities. Act as a regulatory expert within the Virtual Site Operating Team (VSOT), advising of regulatory strategy and potential supply constraints if applicable. Support in Dossier Compliance Assessment and New Regulations/compendia requirements implementation as required. Actively contribute to support investigations into regulatory discrepancies and any other relevant support as needed for the role. Manage complaints for commercial Drug Product and Medical Device and Combination Product, ensuring that investigation reports are appropriate and acceptable as per Pfizer’s requirement. Review and approve SAP material master workflow tasks for completeness and correctness across enterprise and plant-level data. Here Is What You Need (Minimum Requirements) Minimally 2 years of experience in GXP setting and/or Regulatory Affairs role (or 1 year with Master’s degree). Expertise in Change Management and/or Regulatory. Demonstrated knowledge of US, European and global cGMPs, compliance issues, inspectional trends, industry quality assurance practices. Embraces innovation and change to find solutions. Collaborative and embraces Pfizer mindset: Courage, Equity, Excellence, Joy. Proficient in English and technical writing. Good verbal, written communication, and presentation skills. Bonus Points If You Have (Preferred Requirements) Ability to work effectively as a team member within a matrix environment Fundamental understanding of the principles and concepts of QA and GMP Experience in quality assurance or quality control within the pharmaceutical industry Knowledge of regulatory requirements and guidelines Experience with supplier quality management Strong interpersonal skills and the ability to work collaboratively with cross-functional teams Ability to adapt to changing priorities and work in a fast-paced environment Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use Work Location Assignment: Hybrid Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates. To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers . Quality Assurance and Control